MAUDE Adverse Event Report: ORTHOFIX SRL ORTHOFIX MODULSYSTEM; OSTEOTITE BONE SCREW

Model Number	99-60138 (2)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Information provided states that during the application of the external fixator the surgeon pre-drilled using a 3.2mm drill bit.The 1st screw broke while being implanted in the tibia.The 2nd bone screw broke once the screw was completely in the bone and being tightened down.The threaded section of both bone screws remain implanted in the patient's tibia.

• Brand Name: ORTHOFIX MODULSYSTEM
• Common Device Name: OSTEOTITE BONE SCREW
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni 9; bussolengo, verona 37012 ; IT 37012
• MDR Report Key: 7616606
• Report Number: 2183449-2018-00015
• Device Sequence Number: 1898210
• Product Code: JDW
• UDI-Device Identifier: 18032568861815
• UDI-Public: 18032568861815
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/18/2018
• Report Date (Section F): 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: 99-60138 (2)
• Device Lot Number: V1382507,V1389095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/21/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 12 YR
• Patient Weight: 68
• Date Report Sent to FDA: 06/18/2018